Ultrasonic Generator USG-400 (UDI 04953170306747)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04953170306747), received between Sep 27, 2016 and Mar 2, 2023 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2023Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED WITH AN ISSUE OF "FALLING APART". NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475689 ↗
• MalfunctionMar 2, 2023Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED WITH AN ISSUE OF "FALLING APART". NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475657 ↗
• MalfunctionFeb 10, 2023Material Integrity Problem; Material Integrity Problem

  CUSTOMER CONFIRMED THERE WAS NO PATIENT OR USER INJURY DUE TO THE DAMAGED SCREEN. THEY WERE UNSURE WHEN THE SCREEN WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358900 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "OUTCOME OF TRANSORAL ENDOSCOPIC THYROIDECTOMY VESTIBULAR APPROACH (TOETVA) IN COMPARISON WITH OPEN THYROIDECTOMY FOR BENIGN THYROID NODULES" BY SADQ GHALEB KADEM, ET AL. ABSTRACT OPEN THYROIDECTOMY; IS THE GOLD STANDARD SURGICAL PROCEDURE FOR THYROID DISEASES, BUT THE INCISION SCAR IN THE ANTERIOR ASPECT OF THE NECK DUE TO THIS APPROACH CANNOT BE AVOIDED AND MAY RESULTS IN A PERMANENT COSMETIC DEFECT. THEREFORE, THERE IS A NEED TO IMPROVE POSTOPERATIVE QUALITY OF LIFE, INCLUDING COSMETICS. RECENTLY, TRANSORAL ENDOSCOPIC THYROIDECTOMY HAS BEEN DEVELOPED; IT IS A NATURAL ORIFICE THYROID SURGERY, MINIMALLY INVASIVE AND COMPLETELY SCAR FREE. THIS STUDY AIMED TO DESCRIBE THE OUTCOME, PATIENT¿S SATISFACTION, AND COMPLICATIONS AFTER HEMITHYROIDECTOMY FOR BENIGN THYROID NODULES BY TRANSORAL ENDOSCOPIC VESTIBULAR APPROACH IN COMPARISON WITH OPEN APPROACH. THIS STUDY WAS CONDUCTED IN (B)(6), (B)(6) FROM AUGUST 2017 TO JUNE 2019 AND WAS APPROVED BY A LOCAL ETHICAL COMMITTEE. FIFTY PATIENTS WITH BENIGN THYROID NODULES WHO ARE CANDIDATE FOR HEMITHYROIDECTOMY WERE INCLUDED IN THE STUDY; THEY WERE DIVIDED INTO TWO GROUPS ACCORDING TO THE METHOD FO

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Nerve Damage

  MAUDE report 14015263 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: THE INTENDED PROCEDURE WAS A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A PROCEDURAL DELAY. IT IS UNKNOWN IF THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE. THE SMALL BOWEL THERMAL INJURY WAS OVERSEWN WITH THREE LEMBERT SUTURES.

  Patient problems: Burn(s)

  MAUDE report 13498574 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER RETURNED THE SUBJECT DEVICE FOR SERVICE AND INFORMED OLYMPUS THE PATIENT EXPERIENCED A 3MM SEROSAL THERMAL INJURY TO THE SMALL BOWEL. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION ARE IN PROGRESS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13498487 ↗
• InjurySep 29, 2021Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO OLYMPUS THE ULTRASONIC GENERATOR DISPLAYED AN INCORRECT CONNECTION MESSAGE DURING AN UNKNOWN PROCEDURE. THE CUSTOMER STATED THE PATIENT WAS BLEEDING WHILE ON THE EXAM TABLE. THE AMOUNT OF BLOOD LOSS THE PATIENT SUSTAINED IS UNKNOWN. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE IN ANOTHER PROCEDURE ROOM. THE PATIENT DID NOT EXPERIENCE FURTHER BLOOD LOSS AND RECOVERED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12548507 ↗
• InjurySep 29, 2021Device Displays Incorrect Message

  THE CUSTOMER REPORTED TO OLYMPUS THE ULTRASONIC GENERATOR DISPLAYED AN INCORRECT CONNECTION MESSAGE DURING AN UNKNOWN PROCEDURE. THE CUSTOMER STATED THE PATIENT WAS BLEEDING WHILE ON THE EXAM TABLE. THE AMOUNT OF BLOOD LOSS THE PATIENT SUSTAINED IS UNKNOWN. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE IN ANOTHER PROCEDURE ROOM. THE PATIENT DID NOT EXPERIENCE FURTHER BLOOD LOSS AND RECOVERED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12548492 ↗
• MalfunctionMar 26, 2020Activation Problem; Activation Problem

  IT WAS REPORTED THAT DURING A THERAPEUTIC PROCEDURE AN ERROR MESSAGE OF ¿SHORT CIRCUIT ERROR¿ OCCURRED. THE DEVICE ACCORDING TO THE USER WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE OBSERVED. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT INJURY OR HARM REPORTED DUE TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9884914 ↗
• InjuryAug 25, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURN INJURY DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE FOR AN ECTOPIC PREGNANCY WHILE USING A USG-400 GENERATOR. A WEEK LATER THE PATIENT WAS EXPERIENCING BLOATING. THE PATIENT WAS RE-SCOPED ON (B)(6) 2019 AND THE PHYSICIAN FOUND BURNED TISSUE IN THE PATIENT. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY AND THE SURGEON REMOVED THE PATIENT'S APPENDIX AND CECUM. THERE WAS NO FURTHER PATIENT INJURY OR HARM REPORTED AFTER THIS PROCEDURE.

  Patient problems: Abdominal Distention; Burn, Thermal

  MAUDE report 8928948 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURN INJURY DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE FOR AN ECTOPIC PREGNANCY WHILE USING A USG-400 GENERATOR. A WEEK LATER THE PATIENT WAS EXPERIENCING BLOATING. THE PATIENT WAS RE-SCOPED ON (B)(6) 2019 AND THE PHYSICIAN FOUND BURNED TISSUE IN THE PATIENT. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY AND THE SURGEON REMOVED THE PATIENT'S APPENDIX AND CECUM. THERE WAS NO FURTHER PATIENT INJURY OR HARM REPORTED AFTER THIS PROCEDURE.

  Patient problems: Bowel Burn

  MAUDE report 8922121 ↗
• MalfunctionSep 27, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE SUBJECT DEVICE WAS USED DURING AN UNCERTAIN PROCEDURE OF ESOPHAGUS. THE SOUND OF DEVICE ACTIVATION GRADUALLY LESSENED AND FINALLY IT WAS IMPOSSIBLE TO HEAR THE SOUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER USG-400. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5982302 ↗